A massive SHIFT is coming!! | Jason Shurka + 12 Special Speakers & Guests | July 9 & 10 | UNIFYD.TV

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Big Pharma Money ‘Permeates’ World’s Drug Regulatory Agencies, BMJ Investigation Shows | By Michael Nevradakis, Ph.D. | the Defender | ChildrensHealthDefense.org

Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate, according to an investigative report published Thursday by The BMJ.

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Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate, according to an investigative report published Thursday by The BMJ.

The report examines whether drug regulators in six countries, including the U.S., “have sufficient independence from the companies they are meant to regulate.”

Investigative journalist Maryanne Demasi found significant conflicts of interest have developed between drugmakers and the agencies charged with drug regulation, resulting in a negative impact on the quality of pharmaceutical products that reach the public.

In all 6 countries, ‘Big Pharma’ provided bulk of drug regulator funding

The issue of conflicts of interest between pharmaceutical regulators and “Big Pharma” is not new. Demasi referred to a 2005 example from the U.K., where the House of Commons health committee investigated the drug industry’s influence on health policy, including the Medicines and Healthcare Products Regulatory Agency (MHRA), the U.K. equivalent of the U.S. Food and Drug Administration.

The committee expressed concern that pharma’s funding of the MHRA and similar agencies could lead them to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.”

“Nearly two decades on, little has changed,” Demasi reported. “Industry funding of drug regulators has become the international norm.”

Demasi based her conclusion on interviews with regulators in Australia, Canada, Europe, Japan, the U.K. and the U.S.

She asked them about their funding, the level of transparency in their decision-making and data and their drug approval processes.

According to Demasi, her findings broadly indicate, “industry money permeates the globe’s leading regulators, raising questions about their independence, especially in the wake of a string of drug and device scandals.”

Demasi said “industry money saturates the globe’s leading regulators,” with the majority of their budgets — “particularly the portion focused on drugs” — coming from the pharmaceutical industry.

For instance, the FDA, despite being the most highly funded of the six regulatory authorities studied, receives 65% of its funding for drug evaluation from industry user fees.

Continued on Source: Big Pharma Money ‘Permeates’ World’s Drug Regulatory Agencies, BMJ Investigation Shows

$3.2 Billon Taxpayer-Funded Deal With Pfizer Will ‘Enrich Shareholders of Most Profitable Industry in History’ | By Megan Redshaw | the Defender | ChildrensHealthDefense.org

The Biden administration on Wednesday announced a $3.2 billion deal to purchase 105 million doses of Pfizer’s COVID-19 vaccine for a fall vaccination campaign, with options to buy up to 300 million doses.

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The Biden administration on Wednesday announced a $3.2 billion deal to purchase 105 million doses of Pfizer’s COVID-19 vaccine for a fall vaccination campaign, with options to buy up to 300 million doses.

The contract includes a combination of adult and pediatric doses, and supplies of a re-formulated booster shot that will contain the original Wuhan variant and BA.4 and BA.5 Omicron subvariants.

The U.S. Food and Drug Administration (FDA) on Thursday advised COVID-19 vaccine manufacturers to produce the updated booster vaccine — which has not yet undergone human clinical trials — for this fall.

“This agreement will provide additional doses for U.S. residents and help cope with the next COVID-19 wave,” Sean Marett, chief business and chief commercial officer of BioNTech, said in a statement. “Pending regulatory authorization, it will also include an Omicron-adapted vaccine, which we believe is important to address the rapidly spreading Omicron variant.”

The announcement followed Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, which recommended including an Omicron component in future COVID-19 booster vaccines.

“Vaccines have been a game-changer in our fight against COVID-19, allowing people to return to normal activities knowing that vaccines protect from severe illness,” said Xavier Becerra, secretary of the U.S. Department of Health and Human Services (HHS).

“The Biden-Harris Administration is committed to doing everything we can to continue to make vaccines free and widely available to Americans — and this is an important first step to preparing us for the fall.”

However, U.S. taxpayers will fund the $3.2 billion campaign, just as they also paid $1.95 billion for the original 100 million doses obtained under Operation Warp Speed, and $19.50 per dose for 500 million more doses obtained through the government’s option contract.

“Earlier this month, in the absence of additional COVID-19 funding from Congress, the Administration was forced to reallocate $10 billion in existing funding, pulling billions of dollars from COVID-19 response efforts in order to pay for additional vaccines and treatments,” HHS said in a statement. “The funding for this new Pfizer contract is being paid for with a portion of that reallocated funding.”

“The White House has dropped all pretense that this is about protecting public health,” said Robert F. Kennedy, Jr., chairman and chief legal counsel for Children’s Health Defense. “This is an unsheathed, corporate welfare project to further enrich the shareholders of the most profitable industry in history.”

“It’s almost as if these states — and their citizens — are paying for these vaccines twice over: once to bankroll much, or nearly all, of the research itself, then again to buy back the products of this public-funded research,” Quartz reported last month. “Pharma corporations benefit hugely from this model.”

Pfizer said in May it expects about $32 billion in COVID-19 vaccine sales for 2022, but the figure was based on agreements signed before the new contract announced this week.

Pfizer on June 23 approved a quarterly cash dividend of $0.40 per share.

Continued on Source: $3.2 Billon Taxpayer-Funded Deal With Pfizer Will ‘Enrich Shareholders of Most Profitable Industry in History’

Shots for Tots Rollout Flops in NYC

COVID-19 shots for babies and young children were granted Emergency Use Authorization last week, but this week’s low turnout at vaccine centers in New York City and around the country shows parents are not convinced their kids need the vaccine.

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The response to the rollout of COVID-19 vaccines for babies and young children has been tepid, said political commentator Kim Iversen of The Hill’s “Rising” on Thursday.

A push to vaccinate children 6 months to 5 years old began early this week, after the U.S. Food and Drug Administration (FDA) on June 17 granted Emergency Use Authorization for Moderna’s COVID-19 vaccine in children 6 months through 17 years, and the Pfizer-BioNTech vaccine in children 6 months through 4 years.

In a June 17 news release, FDA Commissioner Dr. Robert M. Califf said, “Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age.”

But maybe not, said Iversen.

“There’s a problem,” Iversen said. “Parents don’t seem to want it. News outlets across the country have been reporting about low turnout and empty centers.”

While this might be expected in certain parts of the country, such as red states and especially Florida — where Gov. Ron DeSantis did not order any shots for this age group — “this was even happening in New York City at a high-profile center set up in Times Square,” Iversen said:

“The city’s health commissioner came out with cameras, hoping to greet long lines of relieved, grateful parents but instead saw the opposite: no lines and empty chairs.”

“Turns out parents are not convinced their tots need the shots after all.”

Continued on Source: Shots for Tots Rollout Flops in NYC

Fauci Gets COVID Again After Taking Pfizer’s Treatment — the Drug That Cost Taxpayers $10.5 Billion | the Defender | ChildrensHealthDefense.org 

Dr. Anthony Fauci said Tuesday he is experiencing a rebound of COVID-19 symptoms after taking Paxlovid, Pfizer’s COVID-19 antiviral pill. Taxpayers are on the hook for $10.5 billion worth of the experimental treatment, under a deal the White House cut with Pfizer.

 

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and chief medical advisor to President Biden, said Tuesday he is experiencing a rebound of COVID-19 symptoms after taking Paxlovid, Pfizer’s COVID-19 antiviral pill, Bloomberg reported.

Fauci tested positive for COVID-19 on June 15, despite being quadruple-vaccinated, initially experiencing “mild symptoms,” according to the NIAID.

Due to his age — 81 — which put him at high risk for developing complications, Fauci was prescribed Paxlovid.

The drug, which is made from a combination of nirmatrelvir and ritonavir, in December 2021 was granted Emergency Use Authorization to treat COVID-19.

“After I finished the five days of Paxlovid, I reverted to negative on an antigen test for three days in a row,” Fauci said Tuesday in a remote interview during the Foreign Policy’s Global Health Forum.

“And then on the fourth day, just to be absolutely certain, I tested myself again. I reverted back to positive.”

Continued on Source: Fauci Gets COVID Again After Taking Pfizer’s Treatment — the Drug That Cost Taxpayers $10.5 Billion

CDC Approves COVID Vaccines for Youngest Kids + More | By The Defender Staff | ChildrensHealthDefense.org

The Defender’s COVID NewsWatch provides a roundup of the latest headlines related to the SARS CoV-2 virus, including its origins and COVID vaccines.

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CDC Approves COVID Vaccines for Youngest Kids

NBC News reported:

On Saturday, the Centers for Disease Control and Prevention Director Dr. Rochelle Walensky signed off on COVID vaccines for the youngest Americans. Her endorsement means shots can begin immediately, finally ending the two-and-a-half-year wait on the part of parents of children under 5.

Walenksy accepted the recommendation within hours after the CDC advisory committee voted unanimously in favor of the Pfizer-BioNTech and Moderna vaccines for children as young as 6 months.

A Centers for Disease Control and Prevention advisory committee on Saturday endorsed Pfizer-BioNTech and Moderna’s COVID-19 vaccines for the youngest children, the last step before CDC Director Dr. Rochelle Walensky could issue her final sign-off.

The unanimous recommendations from the CDC’s Advisory Committee on Immunization Practices followed the Food and Drug Administration’s authorization of the shots on Friday.

White House Health Official Makes False Claim About COVID Vaccines

The Epoch Times reported:

Continue on Source: CDC Approves COVID Vaccines for Youngest Kids + More

Pfizer Classified Almost All Severe Adverse Events During COVID Vaccine Trials ‘Not Related to Shots’ | By Michael Nevradakis, Ph.D. | the Defender | ChildrensHealthDefense.org

The case reports included in Pfizer clinical trial documents, released June 1 by the U.S. Food and Drug Administration, reveal a trend of classifying almost all adverse events — and in particular severe adverse events — as being “not related” to the vaccine.

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The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died.

The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide.

The FDA on June 1 released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.

Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and public health professionals, submitted the FOIA request.

CRFs show deaths, severe reactions to the vaccines during Phase 3 trials

The CRFs included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants.

They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being “not related” to the vaccine.

For example:

  • A female in her early 50s (randomization number 86545) who participated in the trial at the Sterling Research Group in Cincinnati, Ohio, died of an apparent myocardial infarction on Nov. 4, 2020. She had received two doses of the vaccine, on Sept. 10 and Sept. 29, 2020.

The patient had a medical history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, osteoarthritis of the knees and attention deficit disorder. Her death was listed as “not related” to the vaccine, and was instead attributed to “hypertensive cardiovascular disease.”

  • A female in her late 50s (randomization number 220496), who participated in the trial at Cincinnati Children’s Hospital Medical Center, died of cardiac arrest on Oct. 21, 2020. Her death, however, was indicated as “not related” to her vaccinations (which occurred on July 30, 2020, and Aug. 20, 2020) as it “occurred 2 months after last receipt of study agent,” according to her CRF.

The participant’s medical history included obesity, placement of a gastric sleeve, gastroesophageal reflux, sleep apnea, supraventricular tachycardia, hypothyroidism, depression and asthma.

Continued on Source: Pfizer Classified Almost All Severe Adverse Events During COVID Vaccine Trials ‘Not Related to Shots’

CDC Admits It Never Monitored VAERS for COVID Vaccine Safety Signals | By Josh Guetzkow, Ph.D. | the Defender | ChildrensHealthDefense.org

In response to a Freedom of Information Request submitted by Children’s Health Defense, the Centers for Disease Control and Prevention last week admitted it never analyzed the Vaccine Adverse Event Reporting System for safety signals for COVID-19 vaccines.

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In a stunning development, the Centers for Disease Control and Prevention (CDC) last week admitted — despite assurances to the contrary — the agency never analyzed the Vaccine Adverse Event Reporting System (VAERS) for safety signals for COVID-19 vaccines.

The admission was revealed in response to a Freedom of Information Act (FOIA) request submitted by Children’s Health Defense (CHD).

In September 2021, I published an article in The Defender in which I used the CDC’s published methodology to analyze VAERS for safety signals from COVID-19 vaccines.

The signals were loud and clear, leading me to wonder “why is nobody listening?”

Instead, I should have asked, “Is anybody even looking for them?”

After that article was published, I urged CHD’s legal team to submit a FOIA request to the CDC about its VAERS monitoring activities.

Since CDC officials stated publicly that “COVID-19 vaccine safety monitoring is the most robust in U.S. history,” I had assumed that at the very least, CDC officials were monitoring VAERS using the methods they described in a briefing document posted on the CDC website in January 2021 (and updated in February 2022, with minor changes).

I was wrong.

Continued on Source: CDC Admits It Never Monitored VAERS for COVID Vaccine Safety Signals

The FLCCC Protocol for COVID-19 Jab Injuries | Analysis by Dr. Joseph Mercola | Fact Checked

STORY AT-A-GLANCE

  • COVID-19 is clearly no longer an emergency. The real emergency now is the continued use of the COVID “vaccines,” because they’re creating injuries on a level that is truly alarming and unprecedented. VAERS data reveal the COVID jabs have caused more harm in 18 months than all other vaccines on the market, combined, over the past three decades
  • Raw data from the Pfizer trial also show the shots were associated with an increased risk for death from the start, and both Pfizer and the FDA knew it
  • Data also show highly “vaccinated” and boosted nations are now experiencing record case and death rates from COVID compared to countries with low injection rates
  • We’re now finding the COVID shots have negative efficacy, meaning, if you have received the shot and are exposed to COVID, you are more likely to get sick, not less likely, compared to someone who is unvaccinated
  • The Frontline COVID-19 Critical Care Alliance (FLCCC) has developed a protocol for those injured by the COVID jabs called I-RECOVER, which you can download from covid19criticalcare.com in several different languages

In the “Tea Time” episode above, Drs. Pierre Kory and Paul Marik review the Frontline COVID-19 Critical Care Alliance (FLCCC) protocol for those injured by the COVID jabs. They also discuss what’s in the shots, their lack of safety and efficacy, adverse events, and the controversial issue of “shedding.”

Kory and Marik are both part of the FLCCC, which was founded in 2020 to share early treatment protocols for COVID-19. Kory is an ICU specialist, triple board certified in internal medicine, critical care and pulmonary medicine. He now runs a private tele-health practice specializing in the treatment of COVID-19, so-called “long-COVID” and vaccine injuries.

Marik is one of the most-published ICU specialists in the world, and best known for his vitamin C protocol for sepsis. The FLCCC’s protocol for COVID is known as the MATH+ protocol, which has undergone multiple revisions over the course of the pandemic.

Now, as injuries from the COVID jab are stacking up, they’ve also added a post-vaccine treatment called I-RECOVER,1 which you can download from covid19criticalcare.com in several different languages.

Continue reading on Source: The FLCCC Protocol for COVID-19 Jab Injuries